Abiomed ’s Successful Pilot Study Leads to Pivotal Trial

Abiomed shares were down as much as 17% despite announcing positive data for its Impella CP. The Danvers, MA-based company presented the data from the 50-patient pilot trial at the American Heart Association annual conference in Chicago and said because of the favorable data it would now move to a pivotal trial. The results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately. The results were simultaneously published in Circulation. Unloading first and delaying reperfusion by 30 minutes did not increase 30-day major adverse cardiovascular and cerebrovascular events (MACCE) or infarct size, compared to the immediate reperfusion arm of the trial. Infarct size is a measure of damage to the heart muscle after a heart attack. It is feasible to delay reperfusion in a heart attack (STEMI) patient in a clinical trial, as demonstrated by a 100% adherence to the 30-minute unloading protocol and 100% Impella CP insertion success in both study arms. Unloading the left ventricle for 30 minutes prior to reperfusion appears to reduce infarct size as a percentage of area at risk among patients with a ST sum greater than 6. “If a reduction of infarct size from unload...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news

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In patients with refractory heart failure, there is increasing interest in the use of temporary mechanical circulatory support devices as a bridge to recovery or advanced cardiac therapies. One such family of devices, Impella (ABIOMED), is approved for use in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), but has seen increased use in non-AMI-CS. The goal of this study was to better characterize patient selection for device implantation and outcomes among a contemporary cohort of patients supported with Impella for cardiogenic shock.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 451 Source Type: research
Right ventricular failure (RVF) is associated with increased mortality among patients receiving left ventricular mechanical circulatory support (LV-MCS) for cardiogenic shock and requires prompt recognition and management. Increased central venous pressure (CVP) is an indicator of potential RVF. We analyzed the association between hemodynamic parameters and clinical outcomes among 132 patients with cardiogenic shock due to acute myocardial infarction in the cVAD registry who had a CVP measured during left-sided Impella support.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 151 Source Type: research
[Short version of the 2nd edition of the German-Austrian S3 guidelines "Cardiogenic shock complicating myocardial infarction-Diagnosis, monitoring and treatment"]. Anaesthesist. 2020 Sep 30;: Authors: Werdan K, Boeken U, Briegel MJ, Buerke M, Geppert A, Janssens U, Kelm M, Michels G, Pilarczyk K, Schlitt A, Thiele H, Willems S, Zeymer U, Zwißler B, Delle-Karth G, Ferrari M, Figulla H, Heller A, Hindricks G, Pichler-Cetin E, Pieske BM, Prondzinsky R, Thielmann M, Bauersachs J, Kopp I, Ruß M Abstract BACKGROUND: The present guidelines ( http://leitlinien.net ) focus exclusively on ...
Source: Der Anaesthesist - Category: Anesthesiology Authors: Tags: Anaesthesist Source Type: research
Conclusion LMWH could reduce the risk of major bleeding in patients receiving IABP. Whether LMWH could reduce arterial thromboembolism needs further investigation. [...] Georg Thieme Verlag KG Stuttgart · New YorkArticle in Thieme eJournals: Table of contents  |  Abstract  |  open access Full text
Source: The Thoracic and Cardiovascular Surgeon - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Original Cardiovascular Source Type: research
Cardiogenic shock remains a challenging, heterogenous clinical entity with high mortality. Despite numerous advances in the treatment of coronary artery disease and cardiac critical care, mortality for patients with cardiogenic shock after acute myocardial infarction (AMI) remains as high as 50%.1-3 The mortality for patients with cardiogenic shock from other etiologies is less clear, but may be higher in some subgroups, such as those with acute on chronic heart failure without options for advanced therapies.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Source Type: research
AbstractPurpose of ReviewWe aim to summarize recent insights and provide an up-to-date overview on the role of intra-aortic balloon pump (IABP) counterpulsation in cardiogenic shock (CS).Recent FindingsIn the largest randomized controlled trial (RCT) of patients with CS after acute myocardial infarction (AMICS), IABP did not lower mortality. However, recent data suggest a role for IABP in patients who have persistent ischemia after revascularization. Moreover, in the growing population of CS not caused by acute coronary syndrome (ACS), multiple retrospective studies and one small RCT report on significant hemodynamic impro...
Source: Current Heart Failure Reports - Category: Cardiology Source Type: research
Abstract A number of devices can now provide mechanical circulatory support (MCS) to patients with acute cardiogenic shock (CS) and chronic end-stage heart failure (HF). Women differ from men in pathophysiology and natural history of CS and HF, and are usually sicker at admission. Current evidence suggests that women benefit as much as men, if not more, from both temporary and durable MCS for appropriate indications. Yet, women have been under-represented in clinical trials of MCS devices. Limited evidence suggests that women benefit more from temporary MCS in CS associated with acute myocardial infarction. Howeve...
Source: Journal of Cardiology - Category: Cardiology Authors: Tags: J Cardiol Source Type: research
Conclusion: Increased serum endothelin-1 on-admission correlated with increased troponin-I and independently predicted in-hospital adverse cardiac events in patients with Non-STEMI. PMID: 32832158 [PubMed]
Source: International Journal of Vascular Medicine - Category: Cardiology Tags: Int J Vasc Med Source Type: research
Conclusions. Mortality in STEMI patients identified and treated by paramedics was low, and the prehospital fibrinolysis treatment pathway was effective with a mortality rate comparable to that of patients undergoing primary PCI. PMID: 32790490 [PubMed - as supplied by publisher]
Source: Prehospital Emergency Care - Category: Endocrinology Tags: Prehosp Emerg Care Source Type: research
Conclusion: The PDMPs level was increased from the day of admission to 30 days after discharge in patients with STEMI. The persistent increase in the PDMPs level in 30 days after the STEMI event was associated with the 30-day postdischarge MACE and trended toward increased MACE during the 90-day and 1-year follow-up. PMID: 32695505 [PubMed]
Source: Cardiology Research and Practice - Category: Cardiology Authors: Tags: Cardiol Res Pract Source Type: research
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